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CTRI Number  CTRI/2025/05/086530 [Registered on: 07/05/2025] Trial Registered Prospectively
Last Modified On: 24/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   “A CLINICAL STUDY TO EVALUATE THE EFFICACY OF AYURVEDIC MEDICINE IN THE MANAGEMENT OF DIABETES IN OBESE PATIENTS  
Scientific Title of Study   A RANDOMIZED DOUBLE ARM COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF THE WHOLE SYSTEM AYURVEDA PROTOCOL (WSAP) IN THE MANAGEMENT OF STHULA PRAMEHI VIS-A-VIS DIABETES MELLITUS. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Soumya B Bashetti 
Designation  PG Scholar 
Affiliation  Ayurveda Mahavidyalaya and Hospital Hubballi 
Address  OPD No 05 Department of PG Studies in Kayachikitsa Ayurveda Mahavidyalaya and Hospital Heggeri extension Old Hubli Hubli 580024 Karnataka

Dharwad
KARNATAKA
580024
India 
Phone  9353801914  
Fax    
Email  soumyabb1999@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pramod Katti  
Designation  Professor  
Affiliation  Ayurveda Mahavidyalaya and Hospital Hubballi 
Address  OPD No05 Department of PG Studies in Kayachikitsa Ayurveda Mahavidyalaya and Hospital Heggeri extension Old Hubli Hubli 580024

Dharwad
KARNATAKA
580024
India 
Phone  9886218596  
Fax    
Email  pramodayurveda@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Soumya B Bashetti 
Designation  PG Scholar  
Affiliation  Ayurveda Mahavidyalaya and Hospital Hubballi 
Address  OPD No 05 Department of PG Studies in Kayachikitsa Ayurveda Mahavidyalaya and Hospital Heggeri extension Old Hubli Hubli 580024 Karnataka

Dharwad
KARNATAKA
580024
India 
Phone  9353801914  
Fax    
Email  soumyabb1999@gmail.com  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  Dr Soumya B Bashetti  
Address  Ayurveda Mahavidyalaya and Hospital Heggeri extension Old Hubli Hubli 580024 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrSoumya B Bashetti   Ayurveda Mahavidyalaya and Hospital.  OPD No 05 Department of PG Studies in Kayachikitsa Heggeri extension Old Hubli Hubli 580024
Dharwad
KARNATAKA 		 9353801914

soumyabb1999@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ayurveda Mahavidyalaya hubballi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E119||Type 2 diabetes mellitus without complications. Ayurveda Condition: PRAMEHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-AllopathyTab Metformin 500mg, twice a day, before food for three months.
2Intervention ArmDrugClassical(1) Medicine Name: Jambwadi Ghana Vati , Reference: Yogaratnakara Pramehadyaya, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -Ushnajala), Additional Information: -
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Prameha clinical features
Newly detected cases of diabetes mellitus
subjects of both gender
FBS more than 126mg/dl upto less than 200mg/dl
PPBS more than 200mg/dl upto less than 300mg/dl
HbA1c 6.5- 8%
BMI 22-30 kg/m2 
 
ExclusionCriteria 
Details  Subjects who do not fulfill Inclusion criteria
Subjects with Sahaja Prameha (Insulin Dependent Diabetes Mellitus/Type 1 Diabetes Mellitus)
Subjects with Diabetic complication
Subjects with Fasting Blood Sugar (FBS) more than 200mg/dl. Post Prandial Blood Sugar
(PPBS) less than 300 mg /dl
Subjects with uncontrolled hypertension.
Pregnant women and lactating mother.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
normalize blood sugar level
normalize HbA1c level
reduction in clinical symptoms  		 3 months  
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in weight
Improvement in lipid profile
Overall wellbeing  		 3 months  
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   10/05/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Diabetes Mellitus is a chronic metabolic disease of multifaceted aetiology prevalent all over the world. It is the condition with constant hyperglycaemia results from defects in insulin production or uptake or both. Type 2 Diabetes is the most common reason for hyperglycaemia mainly affecting people around age of 40 with lack of exercises, sedentary lifestyle and faulty diet. In Ayurveda similar condition has been mentioned under the disease spectrum of Prameha. The line of management of Prameha is to aim at the control of hyperglycaemia. This can be achieved with Whole System Ayurveda Protocol (WSAP) which includes the integration of Prameha Chikitsa siddhanta which includes state wise and stage wise treatment. In this case report WSAP in Prameha includes Amapachana, Rookshana, Pathya, Vyayama and Pramehaghna shamanoushadhis according to the Chikitsa sutra of Prameha by Acharya Sushruta.

 
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